Exercise in Pediatric Autologous Stem Cell Transplant Patients (SCORE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by University of Calgary
Sponsor:
Collaborator:
Alberta Children's Hospital
Information provided by (Responsible Party):
Dr. Nicole Culos-Reed, University of Calgary
ClinicalTrials.gov Identifier:
NCT01666015
First received: August 10, 2012
Last updated: August 15, 2012
Last verified: July 2012
  Purpose

Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship and cure various oncologic diseases. However, this therapy is associated with high mortality rates and numerous negative side-effects. The recovery of the immune system is a special concern and plays a key role in the success of this treatment. In healthy populations it is known that exercise plays an important role in immune system regulation, but little is known about the role of exercise in the hematological and immunological recovery of children undergoing hematopoietic stem cell transplant. The Primary objective of this Randomized Controlled Trial is: study the effect of an exercise program on immune cell recovery in patients undergoing autologous stem cell transplantation. The Secondary objective is to determine if an exercise intervention might diminish the deterioration of quality of life, physical fitness, and the acquisition of a sedentary lifestyle.

Methods

Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to 18 years) in the Alberta Children's Hospital will be randomly assigned to an exercise or control group. The exercise group will participate in a two-phase exercise intervention (in and outpatient) from hospitalization until 10 weeks after discharge. The exercise program includes strength, flexibility and aerobic exercise. During the inpatient phase this program will be performed 5 times/week and will be supervised. The outpatient phase will combine a supervised session with two home-based exercise sessions with the use of the Wii device. The control group will follow the standard protocol without any specific exercise program. A range of outcomes, including quantitative and functional recovery of immune system, cytokine levels in serum, NK cells and their subset recovery and function, and gene expression of activating and inhibitory NK cell receptors, body composition, nutrition, quality of life, fatigue, health-related fitness assessment and physical activity levels will be examined, providing the most comprehensive assessment to date.

Discussion We expect to find an improvement in the immunological recovery, quality of life, decreased acquisition of sedentary behavior and less fitness deconditioning.


Condition Intervention
Cancer
Autologous Hematopoietic Stem Cell Transplantation
Other: EXERCISE (EX)
Other: Standard Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Exercise in Pediatric Autologous Stem Cell Transplant Patients: A Randomized Controlled Trial Protocol

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Hematological and Immunological Recovery [ Time Frame: This assessments will be performed at baseline, 7, 14, 28, 56, 84 and 180 days after stem cell transplantation (SCT) ] [ Designated as safety issue: No ]
    Assessment of the impact of the Exercise (EX) intervention on the immune recovery of pediatric autologous SCT patients will be based on four parameters (a) Recovery of different leukocyte cell subset (e.g., T cells, Natural killer cells, B cells, monocytes, neutrophils etc) in peripheral blood by flow cytometry, (b) Expression of activating and inhibitory Killer IRs by Gene expression analysis of 14 KIR genes will be done by RNA based real-time PCR analysis(c) Function of NK cells and their subsets by measuring in-vitro cytokine secretion and degranulation by different NK cell subsets (cytolytic and regulatory NK cells) on incubation with K-562 cell lines and (d) Levels of different pro-inflammatory and regulatory cytokines in serum using a bead-based array on Luminex.


Secondary Outcome Measures:
  • Quality of life (QOL) [ Time Frame: Assessment will be completed at baseline, 30, 90 and 180 days after SCT ] [ Designated as safety issue: No ]
    Will be assessed using the Pediatric quality of life inventory (PedsQL) general and cancer module as a self-report, and PedsQL and Behavior Assessment System for Children (BASC-2) as parent proxy report. Fatigue will be assessed using the multidimensional PedsQL fatigue scale.


Other Outcome Measures:
  • Health-related fitness assessment [ Time Frame: Assessment will be completed at baseline, 30 and 90 days after SCT ] [ Designated as safety issue: No ]

    Body composition; musculoskeletal fitness (flexibility, muscular strength and endurance); functional mobility and cardiorespiratory fitness will be performed.

    Body composition: weight, height, skinfold measure (biceps, triceps, subscapular and suprailiac).

    Flexibility: sit and reach Muscular strength: A hand- held dynamometer will be used to assess grip strength and knee extension.

    Muscular endurance: modified push up, partial curl-up and 30 seconds squat test.

    Functional mobility: Time up and go test (3 meters) Cardiorespiratory fitness: Treadmill submaximal test. Height and tanner stage will be used to determine duration of each stage (2-3 minutes) and initial velocity of the protocol.


  • Physical activity levels [ Time Frame: Assessment will be completed at baseline, 30, 90 and 180 days after SCT ] [ Designated as safety issue: No ]
    A triaxial accelerometer (Actical - Phillips respironic) will be put on when the participant gets up from bed each day and worn until the participant is ready to fall asleep. Subjects can go about their normal, daily activities, including rigorous exercise, swimming or bathing. During each assessment subjects will be instructed to wear the activity monitor over their right hip on an elasticized belt for seven consecutive days. Additionally, participants will be asked to record, in a daily log, the time they put on and took off the monitor each day.

  • Demographic and health assessment [ Time Frame: This assessment will be perfomed at baseline, 15, 30, 60, 90 days after SCT ] [ Designated as safety issue: No ]
    Demographic characteristics, health record information (type of cancer, disease status, co-morbid conditions, cancer treatment received, side-effects of treatment) and information related to SCT (platelet and neutrophil engraftment, conditioning regimen received, toxicities due to conditioning regimen, documented infection, incidence of fever) will be collected. A questionnaires will be filled out by the physician.

  • Dietary intake [ Time Frame: Assessment will be completed at baseline, 30, 90 and 180 days after SCT ] [ Designated as safety issue: No ]
    Usual dietary intake will be assessed using a 3-day dietary record. Dietary records will be analyzed by a Registered Dietitian using Diet Analysis Plus 10.0 software (Thomson Wadsworth, Toronto, Canada.


Estimated Enrollment: 24
Study Start Date: June 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise (EX)
This group will perform two phases of an EX program.
Other: EXERCISE (EX)

This study will examine the effect of two phases of an EX program on several health related outcomes in pediatric patient undergoing autologous SCT. The first phase of the EX program will be an inpatient intervention and will begin when the child is hospitalized undergoing conditioning therapy and will continue until discharge.

The second phase will be a 10-week outpatient intervention, beginning once the child is discharged. We will utilize a mixed EX program, including supervised (at the University of Calgary) and home-based training incorporating the use of the Nintendo ® Wii device™ (Wii Fit, Wii Dance and Sports™ games).

Other Name: PHYSICAL ACTIVITY
Active Comparator: Standard Care
This group will follow the standard care without any EX prescription.
Other: Standard Care
This group will be under standard care without any EX intervention.
Other Name: Active comparator/ control

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • autologous SCT at Alberta Children`s Hospital (ACH) for malignancy
  • age 5 to 18 years of age
  • will be receiving myeloablative conditioning regimen
  • no evidence of cardiac or pulmonary failure associated with treatment (SF≥28%, EF ≥ 50%)
  • no functional nor cognitive limitation that would prohibit performance of the home-based training
  • approval by treating oncologist for participants
  • a parent or legal guardian must sign the consent form and
  • children should express verbal assent to participate.

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666015

Contacts
Contact: Carolina Chamorro-Viña, Ph.D (403) 210-8482 cchamorro@kin.ucalgary.ca
Contact: Karen Mazil, RN,BN (403) 955-2242 karen.mazil@albertahealthservices.ca

Locations
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Carolina Chamorro-Viña, Ph.D    (403) 210- 8482      
Contact: Karen Mazil, RN,BN    (403) 955-2242      
Principal Investigator: Gregory MT Guilcher, MD         
Sub-Investigator: Karen Mazil, RN, BN         
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Carolina Chamorro-Viña, Ph.D    (403) 210-8482    cchamorro@kin.ucalgary.ca   
Sub-Investigator: Carolina Chamorro-Viña, Ph.D         
Principal Investigator: Nicole S Culos-Reed, Ph.D         
Sub-Investigator: Faisal Khan, Ph.D         
Sponsors and Collaborators
University of Calgary
Alberta Children's Hospital
Investigators
Principal Investigator: Nicole S Culos-Reed, Ph.D University of Calgary Faculty of Kinesiology, Faculty of Medicine and Department of Psychosocial Resources, Tom Baker Cancer Centre
Principal Investigator: Carolina Chamorro-Viña, Ph.D Faculty of Kinesiology, University of Calgary.
  More Information

No publications provided by University of Calgary

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Nicole Culos-Reed, Ph.D, Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT01666015     History of Changes
Other Study ID Numbers: RF-CACICPES01, University of Calgary
Study First Received: August 10, 2012
Last Updated: August 15, 2012
Health Authority: Canada:Alberta Children's Hospital Research Institute (ACHRI)

Keywords provided by University of Calgary:
pediatric
exercise
hematopoietic stem cell transplantation
cancer
quality of life
immune system
physical activity levels

ClinicalTrials.gov processed this record on October 01, 2014